Anesthesia Conduction, Anesthetics, Local, Injuries, Hand
Conditions
Keywords
Ropivacaine, Bupivacaine, Upper Extremity, Local anesthetic
Brief summary
The purpose of this study is to determine if bupivacaine (75% levobupivacaine plus 25% racemic bupivacaine) with vasoconstrictor is effective and safety as ropivacaine in brachial plexus block for orthopedic surgery.
Detailed description
The intoxication by Bupivacaine is considered life threatening. Currently the most safety local anesthetic in substitution to bupivacaine is ropivacaine, however in Brasil there is a bupivacaine mixture of 75% levobupivacaine plus 25% racemic bupivacaine. The research design is: Patients involved: 48; age: 18 to 40 years old; both sex; ASA I and II. Surgery: elective upper extremity orthopedic surgery. Anesthesia technique: brachial plexus block. Primary endpoint: cardiovascular safety; analysis by continuous Holter. Secondary endpoint: anesthetic and analgesic efficacy.
Interventions
DRUGBupivacaine
Dosage: 150mg at once for anesthesia induction
DRUGRopivacaine
Single dose of ropivacaine, 150mg
Sponsors
Cristália Produtos Químicos Farmacêuticos Ltda.
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients involved: 48; ASA I and II; * Surgery: elective upper extremity orthopedic surgery.
Exclusion criteria
* Contraindications to anesthesia technique and/or to local anesthetic; * Participation in different trials in the last two months; * Antiretroviral users; * Obesity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiovascular safety | Two days |
Secondary
| Measure | Time frame |
|---|---|
| Anesthesia Analgesia quality | Two days |
Outcome results
None listed